Infliximab (Remicade)

What is it?
Tumour necrosis factor alpha (TNF) is a potent pro-inflammatory cytokine - a substance produced by the white blood cells in response to inflammation leading to ulceration & tissue damage. Infliximab is an antibody (a special kind of protein), which binds and neutralises TNF.

Indications for use
Infliximab is licensed for the treatment of moderate to severely active Crohns disease not responding to steroids and/or immunosuppressants or for fistulizing disease

How is it given?
It is given as an infusion into the vein over a period of approximately two hours. During this time you will be closely monitored in case of possible infusion reactions. It will be necessary to check the blood pressure, pulse, and temperature at half hourly intervals during the infusion and for around one or two hours afterwards.

The dose is calculated according to body weight (5 mg/kg). It is given as a single infusion or may be repeated in eight weekly cycles if signs of relapse occur.

To heal fistulae the same dosage is given, but repeated at two and six weeks after the initial infusion.

Recent research has shown that infliximab is even more effective if it is given at regular intervals, every eight weeks for a full year.

What are the effects?
TNF is produced very early on in the so-called inflammatory chain and is responsible for many other events that occur afterwards. Thus, if TNF is blocked, events leading to tissue damage may be prevented.

Evidence of a response to the treatment, with a reduction, or complete resolution of symptoms, is usually noted at around two to four weeks after the infusion, the benefits lasting for some eight to twelve weeks. A repeat infusion at this time can restore the initial benefits or enhance the effects if only a partial response has been achieved. For some patients a single infusion may be all that is needed.

Will I still need to take my usual medication?
The answer is yes. Despite very promising results Infliximab is not a cure for Crohn’s disease. Once remission has been achieved this will be maintained by your previous medication, diet, or a combination of both.

Research has shown that patients taking drugs such as Azathioprine, have a reduced incidence of relapse following treatment with Infliximab

Are there any side effects?
Infliximab is a new treatment for Crohn’s disease and therefore the full safety profile remains unclear. However patients have been followed up in clinical trials for a period of two years in order to determine safety of treatment and re-treatment.

Patients with heart failure should not take Infliximab. As TNFa is normally produced as part of the body’s defence against infection, Infliximab may allow infections to become more severe. This is particularly important in the case of tuberculosis (TB) . Some people with past exposure to TB may find that the disease becomes reactivated. Sepis may also occur. If you have lived in a region where histoplasmosis is common or if you have any disease that affects the nervous system you should tell you doctor before starting treatment.

Side effects which have occurred during or shortly after the infusion because of hypersensitivity have included:
• Joint and muscle pain
• Fever
• Rash
• Pruritis (itchy skin)
• Facial, hand or lip swelling
• Fifficulty in swallowing
• Sore throat and/or headache

Infusions may need to be slowed down, discontinued or antihistamine treatment given.

Other reported reactions during clinical trials include:
• Viral infection
• Fever
• Headache
• Vertigo/dizziness
• Raised blood pressure
• Flushing
• Chest infection
• Shortness of breath
• Sinusitis
• Diarrhoea
• Abdominal pain
• Nausea
• Indigestion
• Rash
• Itchy/dry skin
• Increased sweating
• Chest pain
• Fatigue

Other effects may occur due to an increased susceptibility to infection or masking of the normal signs of infection due to the blocking of TNF. Speak to your doctor or nurse immediately if you are concerned about any possible side effects you may be experiencing.

Occasionally patients may develop antibodies to the antibody, which may cause allergic reactions. These will need to be dealt with accordingly and treatment with Infliximab stopped.

During clinical trials, one case of lymphoma (cancer of the lymph glands) has been reported nine months after treatment in a patient with longstanding Crohn’s disease and a long history of treatment with steroids and immunosuppressants. This may have been due to the illness itself rather than Infliximab as it is well within the reported incidence of lymphoma in Crohn’s disease. However, this highlights the need for continued monitoring.

Infliximab should be reserved for unresponsive disease.

Although, these potential side effects might seem quite alarming, this treatment is being prescribed because you have a difficult disease which needs to be controlled in order to prevent further complications from developing. If you are anxious about any aspect of your treatment discuss these with the doctor or nurse as soon as possible.

Are there any contraindications?
Infliximab must not be given if there is evidence of infection or the presence of abscesses, or if there have been hypersensitivity reactions on previous infusions.